EUCTR2016-000965-21-IT进行中（未招募）1 期
A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination with Dexamethasone in Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Pomalidomide and/or an anti-CD38 Monoclonal Antibody. - A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination with Dexamethasone in Patients w
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, age 18 years or older.
- •2 A prior diagnosis of multiple myeloma with documented disease progression in need of treatment at time of screening. 3. Measurable disease defined as any of the following:
- •Serum monoclonal protein = 0.5 g/dL (= 5 g/L) by protein electrophoresis (SPEP) = 200 mg/24 hours of monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP) Serum immunoglobulin free light chain =10 mg/dL (= 100 mg/L) AND
- •abnormal serum immunoglobulin kappa to lambda free light chain ratio
- •4. A minimum of 2 prior lines of therapy, including an IMiD and a PI, and is refractory to pomalidomide and/or an anti-CD38 mAb. (Refractory status includes patients who relapse while on therapy or within 60 days of last dose of pomalidomide and/or an anti-CD38 mAb in any line, regardless of response).
- •5. Life expectancy of = 6 months.
- •6. ECOG performance status = 2. (Patients with worse performance status based solely on bone pain secondary to multiple myeloma will be eligible may be eligible following consultation and approval of the medical monitor).).
- •7. Female of child bearing potential (FCBP)* and non-vasectomized male agree to practice appropriate methods of birth control (See Section 7.6.1).
- •8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
- •9. 12-lead ECG with QTcF interval of = 470 msec (Appendix H).
- •10. The following laboratory results must be met during screening
- •(within 21 days) and also prior to study drug administration on Cycle 1 Day 1: Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109/L) (Growth factors cannot be used within 10 days prior initiation of therapy)
- •Platelet count = 75,000 cells/mm3 (75 x 109/L) (without transfusions required during the 10 days prior to initiation of therapy) Hemoglobin = 8.0 g/dl (RBC transfusions are permitted) Total Bilirubin = 1.5 x upper limit of normal (ULN) or higher value in patients diagnosed with Gilberts syndrome after review and approval by the medical monitor.
- •.AST (SGOT) and ALT (SGPT) = 3.0 x ULN
- •Renal function: Estimated creatinine clearance by Cockcroft-Gault formula = 45 mL/min. For women = 155cm in height and with normal BMI (18.5 – 24.9 kg/m2) the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method for calculation of glomerular filtration may be used (Appendix G)
- •11. Must have, or accept to have, an acceptable central catheter for infusion of melflufen (Port a cath, PICC line, or central venous catheter). *(FCBP) is any sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least 24 consecutive months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 95
排除标准
- •1. Evidence of mucosal or internal bleeding and/or is platelet transfusion refractory (i.e., platelet count fails to increase by > 10,000 cells/mm3 after a transfusion of an appropriate dose of platelets)
- •2. Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her
- •participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction (MI), significant conduction system abnormalities, uncontrolled hypertension, = grade 3 thromboembolic event in the last 6 months).
- •3. Active infection treated with parenteral anti-infectives within 14 days, or oral anti-infectives within 7 days, prior to initiation of treatment
- •(exceptions may be considered after review and approval by the medical monitor).
- •4. Primary refractory (never responded (= MR) to any prior therapy)
- •5. Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast and very-low and low risk prostate cancer patients in active surveillance as defined in NCCN version 3.2016.
- •6. Pregnant or breast-feeding females
- •7. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
- •8. Known HIV or active hepatitis B or C viral infection
- •9. Concurrent symptomatic amyloidosis or plasma cell leukemia
- •10. POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes]
- •11. Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy.. IMiDs, PIs and or corticosteroids within 2 weeks prior to initiation of therapy. Investigational therapies and monoclonal antibodies or live vaccines within 4 weeks of initiation of therapy (other washout time may be considered following consultation with the medical monitor). Prednisone up to but no more than 10 mg orally q.d. or its equivalent for
- •symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy.
- •12. Residual side effects to previous therapy > grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy grade 2 without pain are permitted)
- •13. Prior autologous or allogeneic stem cell transplant within 12 weeks of initiation of therapy
- •14. Prior allogeneic stem cell transplant with active graft-versus-hostdisease (GVHD).
- •15. Prior major surgical procedure or radiation therapy within 4 weeks of
- •the first dose of study treatment (this does not include limited course of
- •radiation used for management of bone pain within 7 days of initiation of therapy).
- •16. Known intolerance to steroid therapy
研究者
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